Coadministration of 4CMenB and hexavalent DTPa-HBV-IPV/Hib vaccines moves forward
By Bruce Jancin
MALMO, SWEDEN – Coadministration of multicomponent meningococcal serogroup B vaccine with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type B (DTPa-HBV-IPV/Hib) vaccine demonstrated acceptable immunogenicity and tolerability in an analysis of three published major randomized trials, Elisa Turriani, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
This reassuring finding from the three large GlaxoSmithKline-funded clinical trials provides necessary encouragement for the company: It’s seeking to obtain acceptance for routine coadministration of the vaccines as a means of minimizing immunization visits. Meanwhile, a growing number of countries are considering introducing the company’s recombinant multicomponent meningococcal serogroup B vaccine (4CMenB), known by its brand name as Bexsero, into their national immunization programs, declared Dr. Turriani of GSK in Wavre, Belgium.
“This would improve vaccination coverage and allow infants and young children to benefit from protection against these serious vaccine-preventable infectious diseases, especially in countries where [meningitis B] is the main cause of invasive meningococcal disease,” she observed.
Dr. Turriani further noted that GSK’s DTPa-HBV-IPV/Hib vaccine is at present the only hexavalent vaccine that’s been studied in coadministration with 4CMenB. This took place in a 1,885-infant randomized trial (JAMA. 2012 Feb 8;307:573-82), a 2,627-infant trial (Lancet. 2013 Mar 9;381:825-35), and in a study of 558 infants randomized to prophylactic acetaminophen or not (Hum Vaccin Immunother. 2014 Jul 1;10:1993-2004).
It was important to analyze this collective study experience because coadministration of vaccines can potentially adversely affect immunogenicity and safety. The new analysis demonstrated that immunogenicity of 4CMenB was unimpaired by coadministration with DTPa-HBV-IPV/Hib vaccine.
On the tolerability front, it’s noteworthy that post-dose rates of fever of 38.5° C or higher were consistently higher with coadministration. Indeed, in one study the incidence reached 65.3% – roughly twice the rate seen in controls. Coadministration also was associated with significantly higher rates of injection site tenderness, irritability, and change in eating habits. However, all of these local and systemic reactions were significantly decreased by prophylactic acetaminophen, which had no clinically relevant effects on immune responses to any of the individual vaccines, according to Dr. Turriani.
This analysis was funded by GlaxoSmithKline Biologicals. Dr. Turriani is a company employee.
Dr. Elisa Turriani Credit: Bruce Jancin/MDedge News